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Efficacy and Safety of Orally Administered DS107 in Adult Patients With Moderate to Severe Atopic Dermatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03817190
Recruitment Status : Completed
First Posted : January 25, 2019
Results First Posted : May 6, 2022
Last Update Posted : May 6, 2022
Sponsor:
Information provided by (Responsible Party):
DS Biopharma

Brief Summary:

The objective of this study is to compare the efficacy and safety of orally administered DS107 (2g) versus placebo in the treatment of moderate to severe Atopic Dermatitis (AD).

Oral DS107/Placebo capsules will be administered for 16 weeks. The study will enrol approximately 200 subjects.


Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: DS107 Drug: Placebo Phase 2

Detailed Description:

This study involves a comparison of 2g DS107 with placebo, administered orally once daily for a total of 16 weeks. Patient will be randomized to one of the two treatment arms in a 1:1 ratio.

Patients will come to the clinic on 12 occasions: at Screening/Visit 1, Baseline/Visit 2, Week 2/Visit 3, Week 4/Visit 4, Week 6/Visit 5, Week 8/Visit 6, Week 10/Visit 7, Week 12/Visit 8, Week 14/ Visit 9, Week 16/Visit 10 (end of treatment), Week 18/ Visit 11 (follow up) and Week 20/Visit 12 (follow-up).

The primary endpoint will be the vIGA (Validated Investigator's Global Assessment) and EASI (Eczema Area and Severity Index). Other endpoints include vIGA, EASI, BSA (Body Surface Area) and NRS (Numeric Rating Scale).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 219 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Placebo-controlled, Study to Assess the Efficacy and Safety of Orally Administered DS107 in Adult Patients With Moderate to Severe Atopic Dermatitis
Actual Study Start Date : September 19, 2019
Actual Primary Completion Date : September 3, 2020
Actual Study Completion Date : September 3, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: 2g Oral DS107
2g DS107 (4 DS107 capsules) administered once-daily for 16 weeks
Drug: DS107
DS107 Capsule
Other Name: DGLA

Placebo Comparator: Placebo
Placebo (4 placebo capsules) orally administered once-daily for 16 weeks
Drug: Placebo
Placebo capsule




Primary Outcome Measures :
  1. Proportion of Patients Achieving a Validated Investigator Global Assessment Scale for Atopic Dermatitis Score of 0 or 1 and a Decrease of at Least 2 Points in vIGA-ADTM in Treated Population Compared to Placebo Population From Baseline at Week 16. [ Time Frame: 16 Weeks ]
    Proportion of patients achieving a Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-ADTM) score of 0 (clear) or 1 (almost clear) and a decrease of at least 2 points in vIGA-ADTM in treated population compared to placebo population from Baseline at Week 16 using GLMM.

  2. Proportion of Patients Achieving EASI-75 in Treated Population Compared to Placebo Population at Week 16. [ Time Frame: 16 Weeks ]
    Proportion of patients achieving EASI-75 (≥75% improvement from Baseline) in treated population compared to placebo population at Week 16 using GLMM.


Secondary Outcome Measures :
  1. Proportion of Patients Achieving a vIGA-ADTM Score of 0 or 1 and a Decrease of at Least 2 Points in vIGA-ADTM in Treated Population Compared to Placebo Population From Baseline to Week 4, 8, 12, 18 and 20. [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 18 and Week 20. ]
    Proportion of patients achieving a vIGA-ADTM score of 0 (clear) or 1 (almost clear) and a decrease of at least 2 points in vIGA-ADTM in treated population compared to placebo population from Baseline to Week 4, 8, 12, 18 and 20 and the change in proportion of patients from Week 16 to Week 18 and 20.

  2. Proportion of Patients Achieving EASI-75 in Treated Population Compared to Placebo Population at Weeks 4, 8, 12, 18 and 20. [ Time Frame: Baseline, Week 4, Week 8, Week 12, Week 18 and Week 20. ]
    Proportion of patients achieving EASI-75 (≥75% improvement from Baseline) in treated population compared to placebo population at Weeks 4, 8, 12, 18 and 20.

  3. Change From Baseline in Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-ADTM) Score in Treated Population Compared to Placebo Population to Weeks 4, 8, 12, 16, 18 and 20, and From Week 16 to Week 18 and 20. [ Time Frame: 20 Weeks ]
    The Validated Global Investigator Assessment scale for Atopic DermatitisTM (vIGA-AD) scale awards a score of 0-4 based on a 5-point severity scale from clear to severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease). The scale uses clinical characteristics of erythema, infiltration, papulation and oozing/crusting as scoring guidelines for the overall severity assessment. A decrease in vIGA indicates a positive outcome for the participant.

  4. Change From Baseline in EASI in Treated Population Compared to Placebo Population to Weeks 4, 8, 12, 16, 18 and 20, and From Week 16 to Week 18 and 20. [ Time Frame: Week 20 ]

    Change from Baseline in Eczema Area and Severity Index (EASI) in treated population compared to placebo population to Weeks 4, 8, 12, 16, 18 and 20, and from Week 16 to Week 18 and 20. EASI quantifies the severity of a patient's atopic dermatitis (AD) based on both lesion severity and the percent of body surface area (BSA) affected. The EASI is a composite score ranging from 0-72 that takes into account the degree of erythema, induration/papulation, excoriation, and lichenification (each scored from 0 to 3 separately, half points are permitted) for each of four body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The severity of each sign is assessed using a 4-point scale (half points are permitted):

    • 0 = none
    • 1 = mild
    • 2 = moderate
    • 3 = severe A decrease in EASI indicates a positive outcome for the participant.

  5. Proportion of Patients Achieving a Decrease of at Least 4 Points in Worst Itch Numeric Rating Scale (NRS) in Treated Population Compared to Placebo Population From Baseline to Week 4, 8, 12, 16, 18 and 20. [ Time Frame: Week 20 ]
    Proportion of patients achieving a decrease of at least 4 points in worst itch numeric rating scale in treated population compared to placebo population from Baseline to Week 4, 8, 12, 16, 18 and 20.

  6. Proportion of Patients Achieving a Decrease of at Least 3 Points in Worst Itch NRS in Treated Population Compared to Placebo Population From Baseline to Week 4, 8, 12, 16, 18 and 20. [ Time Frame: Week 20 ]
    Proportion of patients achieving a decrease of at least 3 points in worst itch NRS in treated population compared to placebo population from Baseline to Week 4, 8, 12, 16, 18 and 20.

  7. Change From Baseline in Worst Itch NRS in Treated Population Compared to Placebo Population to Week 4, 8, 12, 16 and 18. [ Time Frame: Week 20 ]
    Change from Baseline in worst itch Numeric Rating Scale (NRS) in treated population compared to placebo population to Week 4, 8, 12, 16 and 18. Severity of pruritus related to atopic dermatitis (AD) was self-assessed by patients daily using the NRS. Patients were asked to estimate the intensity of pruritus at its worst over the previous 24 hours. The Pruritus NRS is a single-question assessment tool that was used to assess the patient's worst itch as a result of AD in the previous 24 hours. Patients will score their pruritus due to AD on a scale of 0 - 10, with 0 indicating no itch and 10 indicating the worst itch imaginable. Patients will complete the rating scale daily starting at screening through to the last study visit. A decrease in worst itch NRS indicates a positive outcome for the participant.

  8. Proportion of Patients Achieving EASI-50 in Treated Population Compared to Placebo Population at Week 4, 8, 12, 16, 18 and 20. [ Time Frame: Week 20 ]
    Proportion of patients achieving EASI-50 (≥50% improvement from Baseline) in treated population compared to placebo population at Week 4, 8, 12, 16, 18 and 20.

  9. Change From Baseline in the Body Surface Area Affected by AD in Treated Population Compared to Placebo Population to Weeks 4, 8, 12, 16, 18 and 20, and From Week 16 to Week 18 and 20. [ Time Frame: Week 20 ]
    Change from Baseline in the Body Surface Area (BSA) affected by AD in treated population compared to placebo population to Weeks 4, 8, 12, 16, 18 and 20, and from Week 16 to Week 18 and 20.

  10. Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Score in Treated Population Compared to Placebo Population to Weeks 4, 8, 12, 16, 18 and 20, and From Week 16 to Week 18 and 20. [ Time Frame: 20 Weeks ]

    The SCORAD grading system was developed by the European Task Force on Atopic Dermatitis and has been a standard tool to assess atopic dermatitis (AD) severity in clinical studies. Six items (erythema, edema/papulation, oozing/crusts, excoriation, lichenification, and dryness) will be selected to evaluate the AD severity. The intensity of each item is graded using a 4-point scale:

    • 0 = No symptoms
    • 1 = Mild
    • 2 = Moderate
    • 3 = Severe The overall body surface area (BSA) affected by AD will be evaluated (from 0 to 100%) and included in the SCORAD scores. Loss of sleep and pruritus will be evaluated by patients on a visual analog scale (0-10). The SCORAD formula is A/5 + 7B/2 + C. In this formula A is defined as the extent (0-100), B is defined as the intensity (0-18) and C is defined as the subjective symptoms (0-20). The sum of these measures represents the SCORAD which can vary from 0 to 103. A decrease in SCORAD indicates a positive outcome for the participant.

  11. Incidence of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs). [ Time Frame: 20 Weeks ]
    Incidence of TEAEs and SAEs.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with a clinically confirmed diagnosis of active AD according to the American Academy of Dermatology Consensus Criteria that had been present for at least 6 months before the screening visit.
  2. Patients with moderate to severe AD at baseline as defined by a Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-ADTM) score of 3 Or 4 at baseline.
  3. Patients with an Eczema Area and Severity Index (EASI) score of ≥16 at screening and baseline.
  4. Patients with AD covering a minimum 10% of the Body Surface Area (BSA) at baseline.
  5. Patients with a worst itch Numeric Rating Scale (NRS) score in a day of ≥4 (on 11-point NRS) at the screening and baseline visits.
  6. Patients whose pre-study clinical laboratory findings did not interfere with their participation in the study, in the opinion of the investigator.
  7. Patients who were able and willing to stop all current treatments for AD throughout the study (except for allowed emollients).
  8. Patients who were on a stable dose of a bland emollient for at least 7 days prior to baseline.
  9. Male or female patients aged 18 years and older on the day of signing the informed consent form (ICF).
  10. Female patients and male patients with female partners of child bearing potential had to use highly effective birth control methods or have a sterilised partner for the duration of the study.
  11. Recent history (within 6 months before the screening visit) of inadequate response to treatment with topical medications or for whom topical treatments were otherwise medically inadvisable (e.g. because of important side effects or safety risks).
  12. Patients who were able to communicate well with the investigator, to understand and comply with the requirements of the study, and understand and sign the written informed consent prior to initiation of any study specific activities or procedures.

Exclusion Criteria:

  1. Patients with other skin conditions that might interfere with AD diagnosis and/or evaluation (such as psoriasis or current active viral, bacterial and fungal topical skin infections) as assessed by the investigator.
  2. Patients who had used systemic treatments that could affect AD less than 4 weeks prior to Baseline Visit (Day 0), e.g. retinoids, methotrexate, cyclosporine, hydroxycarbamide (hydroxyurea), azathioprine and oral/injectable corticosteroids.

    Intranasal corticosteroids and inhaled corticosteroids for stable medical conditions were allowed.

  3. Patients with previous exposure to DS107.
  4. Patients who had used any topical medicated treatment for AD (except for emollients) two weeks prior to start of treatment/Baseline (Day 0) including but not limited to, topical corticosteroids, calcineurin inhibitors, tars, bleach, antimicrobials and bleach baths.
  5. Patients who used emollients containing urea, ceramides or hyaluronic acid less than 12 weeks prior to Baseline (Day 0).
  6. Patients who have had excessive sun exposure, have used tanning booths or other ultraviolet (UV) light sources four weeks prior to Baseline (Day 0) and/or were planning a trip to a sunny climate or to use tanning booths or other UV sources between screening and follow-up visits.
  7. Patients who had a history of hypersensitivity to any substance in DS107 or placebo capsules.
  8. Patients who had a history of hypersensitivity to soy beans or soy lecithin.
  9. Patients who had a white cell count or differential white cell count outside of the normal reference range at screening.
  10. Patients who had any clinically significant controlled or uncontrolled medical condition or laboratory abnormality that would, in the opinion of the investigator, put the patient at undue risk or interfere with interpretation of study results.
  11. Patients who had a clinically significant impairment of renal or hepatic function.
  12. Patients with significant uncontrolled cardiovascular, neurologic, malignant, psychiatric, respiratory or hypertensive disease, as well as uncontrolled diabetes and fluoride arthritis or any other illness that, in the opinion of the investigator, was likely to interfere with completion of the study.
  13. Patients with active infectious diseases (e.g. hepatitis B, hepatitis C or advanced disease secondary to infection with human immunodeficiency virus).
  14. Patients with a history of clinically significant drug or alcohol abuse in the opinion of the investigator in the last year prior to Baseline (Day 0).
  15. Patients who had participated in any other clinical study with an investigational drug within 3 months before the first day of administration of study treatment.
  16. Patients who have had treatment with biologics as follows:

    Any cell-depleting agents including but not limited to rituximab: within 6 months before the screening visit, or until lymphocyte count returned to normal, whichever was longer. b. Other biologics influencing cell proliferation: within 6 months before the screening visit. c. Dupilumab or other monoclonal antibodies within 5 half-lives (if known) or 16 weeks prior to baseline visit, whichever was longer.

  17. Patients who were pregnant, planning pregnancy, breastfeeding and/or were unwilling to use adequate contraception (as specified in Inclusion Criterion 10) during the trial.
  18. Patients, in the opinion of the investigator, not suitable to participate in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03817190


Locations
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Sponsors and Collaborators
DS Biopharma
Investigators
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Study Chair: Markus Weissbach, MD DS Biopharma
  Study Documents (Full-Text)

Documents provided by DS Biopharma:
Study Protocol  [PDF] March 18, 2020
Statistical Analysis Plan  [PDF] September 24, 2020

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Responsible Party: DS Biopharma
ClinicalTrials.gov Identifier: NCT03817190    
Other Study ID Numbers: DS107G-05-AD3
First Posted: January 25, 2019    Key Record Dates
Results First Posted: May 6, 2022
Last Update Posted: May 6, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases